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Last Updated: April 14, 2025

Drugs Containing Excipient (Inactive Ingredient) TRISODIUM CITRATE DIHYDRATE


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Branded drugs containing TRISODIUM CITRATE DIHYDRATE excipient, and estimated key patent expiration / generic entry dates

Generic drugs containing TRISODIUM CITRATE DIHYDRATE excipient

Market Dynamics and Financial Trajectory for Trisodium Citrate Dihydrate

Market Overview

Trisodium citrate dihydrate, also known as citric trisodium salt dihydrate, is a crucial pharmaceutical excipient and food additive. It is produced through the complete neutralization of citric acid with high purity sodium hydroxide or carbonate, followed by crystallization[2][4].

Market Size and Growth

The global trisodium citrate dihydrate market is projected to experience significant growth. By 2027, the market size is forecasted to reach approximately $835 million, growing at a CAGR of 5.9% from 2022 to 2027[4].

Drivers of Market Growth

Increasing Demand from the Pharmaceutical Sector

The pharmaceutical industry is a key driver of the trisodium citrate dihydrate market. The compound is widely used as a buffering agent and stabilizer in medications, particularly in over-the-counter drugs, vitamins, and supplements. As the cold and flu seasons peak, pharmaceutical companies increase production, which in turn boosts the demand for trisodium citrate dihydrate[3].

Food and Beverage Industry

Trisodium citrate dihydrate is also extensively used in the food and beverage sector as an emulsifier, flavoring agent, and preservative. The increasing consumption of processed foods and beverages, especially in regions like Asia-Pacific, contributes to the market's growth. China, India, and Indonesia are significant markets due to their large and growing populations and increasing demand for packaged foods[1][4].

Urbanization and Consumer Awareness

Urbanization and increased consumer awareness about health and nutrition are driving the demand for trisodium citrate dihydrate. As consumers become more health-conscious, the demand for products that use this excipient as a safer alternative to other preservatives is on the rise[1].

Challenges and Restraints

Fluctuating Raw Material Prices

One of the significant challenges facing the trisodium citrate dihydrate market is the fluctuation in raw material prices. Citric acid, a key raw material, is derived from sugar-based sources like corn. Any fluctuations in the agricultural market can lead to price variations, impacting the production costs of trisodium citrate dihydrate[1][3][4].

Shift to Organic Preservatives

There is a growing preference for organic and chemical-free food products, which can negatively impact the market. As consumers become more health-conscious, they are opting for products with fewer chemicals, potentially reducing the demand for trisodium citrate dihydrate[1][4].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region holds the largest share in the trisodium citrate dihydrate market, driven by the increasing demand from the food, beverage, medical, and personal care industries in countries like China, Japan, and India. China, in particular, has become a major chemical manufacturing base due to its cost advantages and shorter licensing procedures[1][4].

North America

In North America, the market is expected to remain stable with moderate upward price trends. The pharmaceutical sector's preparations for increased production during the cold and flu seasons, along with logistical challenges and raw material fluctuations, will shape the market's trajectory[3].

Key Players and Market Strategies

Major players in the trisodium citrate dihydrate market include Cargill Inc., Archer Daniels Midland Co., American Tartaric Products Inc., Gadot Biochemical Industries Ltd., Citrique Belge, Jungbunzlauer, and others. These companies are focusing on technology launches, acquisitions, and R&D activities to maintain their market share and drive growth[1][4].

COVID-19 Impact

The COVID-19 pandemic had a mixed impact on the trisodium citrate dihydrate market. While the demand from the pharmaceutical industry remained relatively stable, the overall market growth was impeded by supply chain disruptions and a lack of raw materials. The pandemic also led to a shift towards home-cooked meals, reducing the demand for processed foods and beverages temporarily[4].

Specifications and Regulatory Compliance

Trisodium citrate dihydrate must comply with various regulatory standards, including the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopeia (USP), the Food Chemicals Codex (FCC), and the Commission Regulation (EU) No. 231/2012. It is available in various granulations and is fully biodegradable[2][5].

Financial Trajectory

The financial trajectory of the trisodium citrate dihydrate market is positive, with a projected CAGR of over 3% to 5.9% during the forecast period. The market is expected to reach significant revenue milestones, driven by increasing demand from the pharmaceutical and food sectors. However, the market must navigate challenges such as raw material price fluctuations and shifting consumer preferences towards organic preservatives[1][3][4].

Key Takeaways

  • The trisodium citrate dihydrate market is expected to grow significantly, driven by demand from the pharmaceutical and food sectors.
  • Asia-Pacific leads the market due to high demand in countries like China, Japan, and India.
  • Fluctuating raw material prices and a shift towards organic preservatives are key challenges.
  • Major players are focusing on technology launches, acquisitions, and R&D to maintain market share.
  • The market is expected to reach $835 million by 2027, growing at a CAGR of 5.9%.

Frequently Asked Questions (FAQs)

Q: What are the primary applications of trisodium citrate dihydrate? A: Trisodium citrate dihydrate is widely used as a buffering agent, stabilizer, emulsifier, and flavoring agent in the pharmaceutical, food, and beverage industries[2][4].

Q: Which region dominates the trisodium citrate dihydrate market? A: The Asia-Pacific region, particularly countries like China, Japan, and India, dominates the market due to high demand from various industries[1][4].

Q: How has the COVID-19 pandemic affected the trisodium citrate dihydrate market? A: The pandemic had a mixed impact, with stable demand from the pharmaceutical sector but reduced demand from the food and beverage sector due to supply chain disruptions and a shift towards home-cooked meals[4].

Q: What are the key challenges facing the trisodium citrate dihydrate market? A: The market faces challenges such as fluctuating raw material prices and a shift in consumer preferences towards organic and chemical-free products[1][3][4].

Q: Who are the major players in the trisodium citrate dihydrate market? A: Major players include Cargill Inc., Archer Daniels Midland Co., American Tartaric Products Inc., Gadot Biochemical Industries Ltd., Citrique Belge, Jungbunzlauer, and others[1][4].

Sources:

  1. Future Market Insights, Sodium Citrate Dihydrate Market Trends & Shares – 2032.
  2. Jungbunzlauer, Trisodium Citrate Dihydrate.
  3. ChemAnalyst, North American Sodium Citrate Dihydrate Market: Stability with Rising Price Pressure in Late 2024.
  4. IndustryARC, Sodium Citrate Dihydrate Market Size Report, 2022-2027.
  5. VWR, tri-Sodium citrate dihydrate ≥99% (by anhydrous basis), granular.

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